First Wave BioPharma Completes Enrollment for Part 2 of RESERVOIR Phase 2 Trial Evaluating FW-COV in COVID-19-Related GI Infections

Rhea-AI Summary

First Wave BioPharma (FWBI) announced the completion of enrollment for Part 2 of the RESERVOIR Phase 2 trial, assessing the efficacy of FW-COV, an oral niclosamide formulation, for COVID-19-related gastrointestinal infections. The trial included 150 participants randomized for either FW-COV or placebo over 14 days, followed by a six-week observation period. Importantly, no drug-related serious adverse events (SAEs) were reported. Top-line data is expected in the first half of 2022, with potential Emergency Use Authorization application later this year pending successful results.

Positive

• Enrollment completed for Part 2 of the RESERVOIR Phase 2 trial with 150 participants.
• No drug-related serious adverse events reported from trial participants.
• Top-line data expected in the first half of 2022.
• Potential for Emergency Use Authorization application based on trial results.

Negative

• None.

No Drug-Related SAEs Reported; Topline Data Expected 1H 2022

Part 2 of RESERVOIR Trial to Evaluate Efficacy of FW-COV, an Oral Formulation of Niclosamide, and Expand Safety Observations on 150 Trial Participants

BOCA RATON, Fla., Jan. 06, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has completed enrollment for Part 2 of the RESERVOIR Phase 2 trial evaluating FW-COV as an outpatient treatment for COVID-19-related gastrointestinal (GI) infections. FW-COV is a proprietary, oral, tablet formulation of micronized niclosamide being developed to remove SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract.

RESERVOIR is designed as a two-part, two-arm, randomized, placebo-controlled Phase 2 study with a primary purpose to confirm the safety of FW-COV and assess the drug’s ability to remove the SARS-CoV-2 (SARS2) virus from the digestive tract. The 150 patients successfully enrolled in Part 2 of the trial were randomized to receive either FW-COV or a placebo treatment for 14 days and will be observed for six weeks following the end of treatment. No FW-COV drug-related serious adverse events (SAEs) have been reported from the trial participants. First Wave BioPharma expects to report top-line data in the first half of 2022.

“We are very pleased to complete enrollment of the second part of the RESERVOIR trial and look forward to reporting top-line data in the coming months,” stated James Sapirstein, President and CEO of First Wave BioPharma. “This is an important milestone for First Wave and the development of FW-COV. Based on the positive safety data observed thus far, combined with earlier published in vitro COVID efficacy data¹ for niclosamide, we believe that FW-COV has the potential to contribute to the global need for new therapies against SARS2. Furthermore, because niclosamide targets the entire virus, and not just the spike protein, we believe that FW-COV may prove effective against multiple strains of COVID-19, including the Delta and Omicron variants. If RESERVOIR is successful and supported by additional data, we anticipate being in a position to submit an Emergency Use Authorization (EUA) application later this year.”

James Pennington, M.D., Chief Medical Officer of First Wave BioPharma, commented, “Safety data thus far indicates that our micronized oral niclosamide therapy is well tolerated, and we believe that further data will demonstrate that FW-COV can add a much-needed new oral anti-viral therapy to the COVID-19 treatment regimen. Millions of patients around the world already suffer complications from COVID-19, and millions more could face similar medical issues as the Omicron variant continues to fuel a surge in new infections.”

Additional information about the RESERVOIR trial can be found at www.covidgi.com and on ClinicalTrials.gov.

About COVID-19 Gastrointestinal Infections
Gastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in approximately 18% of COVID-19 cases.² Of the 57 million individuals who are reported to have contracted COVID-19 in the U.S.,³ this would translate into approximately 10 million patients having GI infection. Of the 295 million cases reported globally,³ it would translate into almost 53 million patients. Furthermore, approximately 10% of patients who were infected with COVID have persistent symptoms months after their initial diagnosis.⁴ Approximately 86% of these COVID “long haulers” are reported to have GI infection symptoms, with 60% continuing to have diarrhea months after their initial infection.⁵ There is some evidence to support the view that the GI tract is a possible reservoir⁶ for persistence and fecal spread of the COVID-19 virus as ACE-2, the entry receptor for COVID-19, is highly expressed on GI cells. There currently is no targeted treatment for COVID GI infections.

About Niclosamide
Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications. In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties. There remains an urgent need to develop new medicines that can be manufactured at large scale quickly to treat COVID-19. Niclosamide was recently identified by the Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19, with potency 40X greater than remdesivir.¹ Additionally, emerging evidence confirms the severe GI-related complications of COVID and potential fecal spread of the virus.⁶ The Company’s clinical trials may establish that patients treated with an oral and non-systemic niclosamide formulation that delivers high local GI concentrations have decreased viral load and GI-associated symptoms of COVID. Importantly, the manufacturing process for niclosamide can be scaled up to supply large populations quickly.

FW-COV
FW-COV is a niclosamide based small molecule which the Company’s clinical trials may establish has anti-viral activity that is effective for the treatment of SARS-CoV-2 (COVID-19) gastrointestinal infections. FW-COV is anticipated to be supplied as an oral immediate release tablet. The formulation to be used has been milled (micronized) to allow superior dissolution in the gut fluids. This in turn may allow local niclosamide concentrations to reach anti-viral levels. Thus, FW-COV has the potential to benefit COVID patients by decreasing viral load in the GI tract, treating infection symptoms and preventing transmission of the virus through fecal spread

About First Wave BioPharma, Inc.
First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. First Wave BioPharma is currently advancing a therapeutic development pipeline populated with multiple clinical stage programs built around its two proprietary technologies – niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. The Company’s niclosamide portfolio is led by two clinical programs in Phase 2 clinical trials: FW-COV, for COVID-19 gastrointestinal infections and FW-UP, for ulcerative proctitis (UP) and ulcerative proctosigmoiditis. Three additional indications of niclosamide, FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients, FW-UC (ulcerative colitis) and FW-CD (Crohn’s disease) are expected to enter the clinic in 2022 and 2023. First Wave BioPharma is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. The Company is headquartered in Boca Raton, Florida. For more information visit www.firstwavebio.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition and its announcement on the Company’s business, operating results and financial prospects; the integration of the First Wave Bio, Inc. business with the Company’s own business; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, FL 33431
Phone: (561) 589-7020
info@azurrx.com

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett / David Schemelia
(212) 375-2665 / (609) 468-9325
jbennett@tiberend.com / dschemelia@tiberend.com

References:
¹ Jeon S, Ko M, Lee J, Choi I, Byun SY, Park S, Shum D, Kim S. 2020. Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs. Antimicrob Agents Chemother 64:e00819-20. https://doi.org/10.1128/AAC.00819-20.
² Gut Journal: Vol 69, Issue 6: 2020; JAMA Network: Vol 3, Issue 6: 2020; Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; Cheung Gastroenterology: Vol. 159, Issue 1: 2020 
³ New York Times. (1/5/22) https://www.nytimes.com/interactive/2021/world/covid-cases.html
⁴ Rubin, R. “As their numbers grow, COVID-19 “Long Haulers” Stump Experts”. https://jamanetwork.com/journals/jama/fullarticle/2771111 September 23, 2020.
⁵ Davis, et al. “Characterizing Long Covid in an International Cohort: 7 Months of Symptoms and their Impact”. https://www.medrxiv.org/content/10.1101/2020.12.24.20248802v2.full.pdf
⁶ Troisi, J et al. COVID-19 and the gastrointestinal tract: Source of infection or merely a target of the inflammatory process following SARS-CoV-2 infection? World J Gastroenterology. Vol. 27 (14): 2021 Apr. 14.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8047540/

FAQ

What is the purpose of the RESERVOIR trial for FWBI's FW-COV?

The RESERVOIR trial aims to evaluate the safety and efficacy of FW-COV, an oral niclosamide formulation, for treating COVID-19-related gastrointestinal infections.

When will First Wave BioPharma report top-line data from the RESERVOIR trial?

Top-line data from the RESERVOIR trial is expected to be reported in the first half of 2022.

Have there been any serious adverse events reported in the RESERVOIR trial?

No drug-related serious adverse events have been reported among the trial participants.

What potential does FW-COV have against COVID-19 variants?

FW-COV may prove effective against multiple strains of COVID-19, including Delta and Omicron, as it targets the entire SARS-CoV-2 virus.

What is niclosamide's role in FW-COV?

Niclosamide, the active ingredient in FW-COV, has shown antiviral properties and is being tested for its ability to reduce the viral load in the gastrointestinal tract.